Do you monitor your heart rate with a mobile phone app, wear a preventative knee brace or even track the quality of your ZZZ’s with a health product designed for home use? If so, you are part of the larger trend of individuals who are purchasing nonmedical-grade home health products designed for consumers rather than patients.

As a result of accessible, inexpensive smartphone apps and a greater desire by consumers to monitor and improve their own health, companies in the home health product design and medical product design space are expanding and stretching boundaries at an unprecedented rate.

What the Difference between Home Health vs. Medical Products?

Medical device designers and manufacturers produce and deliver products that meet rigorous, multi-step FDA testing. Securing FDA approval is no easy task for these design companies because such products must meet extensive criteria. For instance, they must serve to meet a specific, medically diagnosed need. Medical device design companies manufacture products that are often prescribed by physicians to treat, cure, mitigate or prevent a specific disease or medical condition.

Traditionally, many products made by medical product design companies are sold directly to hospitals, medical facilities or health care providers largely bypassing the consumer marketplace. In this way, the costs of such devices are covered by the patients’ health care insurance. Medical product design company, Mindflow Design breaks down some of the major differences in consumer health vs. medical products and explains that home health products:

Are paid for by consumers

Have limited barriers to entry into the market

Often focus on serving a want vs. a medical need

Are often focused on the human element where many medical products ignore human factors testing

However, this line between medical and home health products continues to get more intertwined. For instance, it’s common for one company to both produce industrial design for home health products and medical devices. Consumers have an advantage when a company demonstrates business savvy by staying on top of health and medical trends. They can further benefit when a company strives to create medical product designs for a non-medical product as they tend to be of much higher quality.

Because more companies are creating home health product designs that meet medical-grade standards, consumers are less likely to pay attention to the distinction. That is, shopper may notice if a product is FDA approved, but might not care if it is an official medical device versus a product used for generally defined health purposes.

FDA Approval Isn’t Required for Home Health Product Manufacturing

Conversely, home health product design companies do not require FDA clearance or approval to be manufactured, marketed and sold to consumers on store shelves. Such products don’t exist to serve a medically stated purpose but rather to salve an itch, irritation or health nuisance.

That is, home health product design companies have greater freedom to create products that offer comfort even though this relief may not be scientifically or medically supported. From a business perspective, home health product design companies are more in tuned to the pulse of consumer trends as they market and sell their products directly to ordinary shoppers with no prescription required.

FDA Approves Non-Rx Consumer Goods

Today’s home health product design companies strive to attain FDA approval even though it isn’t necessary for the product to go to market. Why? An industrial design for home health product that’s approved by the FDA will have more to offer consumers as far as validity of the product and product claims. Home health product design companies can gain an edge over the competition if they offer products that are FDA approved. Without this industry oversight, how are consumers to know whether or not the information or output produced from the device or product is accurate or medically relevant.

The segment between home health product design and medical device design overlaps more and more, and this trend is likely to continue. Years ago, you may have needed a prescription for a specific medical device that today is accessible in the over the counter market. For instance, the diagnostics space was once exclusively offered by medical facilities. Today, however, consumers can readily obtain testing devices off the shelf, including pregnancy, cholesterol, glucose or even HIV tests.

Designers are Listening to Consumers and Providing Options

In the past medical device design companies made products that were geared towards health care providers as they were the primary decision maker or purchaser of the product. That is, the physician rather than the patient would choose the best or most suitable medical device design. (This is still true in many cases; patients aren’t likely to determine the best cardiac valve for their surgery.)

That being said, this swinging pendulum is shifting. Today, patients (or consumers) are becoming primary decision makers for choices that involve their health and medical concerns. This is particularly true for choosing medical or health products that can be used for preventative measures before any condition has been diagnosed. As such, consumers (or patients) are using their spending power to have a greater say in the products being consumes in both home health products and medical devices.

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